Roche ’s Actemra/RoActemra becomes the first biologic therapy approved by the FDA for slowing the rate of decline in pulmonary function in adults with systemic sclerosis-associated interstitial lung disease, a rare, debilitating condition
Basel, 05 March 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) approved Actemra®/RoActemra® (tocilizumab) subcutaneous injection for slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD), a debilitating condition with limited treatment options. Actemra/RoActemra is the first biologic therapy approved by the FDA for the treatment of the disease. Systemic sclerosis (SSc), also known as scleroderma, is an often devastating autoimmune disease that worsens over time and has no cure. ...
Source: Roche Media News - March 5, 2021 Category: Pharmaceuticals Source Type: news
Roche SARS-CoV-2 Rapid Antigen Test receives special approval for at-home patient self-testing using nasal swabs in Germany
Basel, 26 February 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced it has been granted special approval by the German Federal Institute for Drugs and Medical Devices (BfArM) to offer the SARS-CoV-2 Rapid Antigen Test using a simple nasal swab for patient self-testing in Germany. (Source: Roche Media News)
Source: Roche Media News - February 26, 2021 Category: Pharmaceuticals Source Type: news
EMA issues advice on casirivimab and imdevimab antibody cocktail for the treatment of mild-to-moderate COVID-19
Basel, 26 February 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) confirmed today that the European Medicines Agency ’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a scientific opinion supporting the use of the investigational antibody cocktail, casirivimab and imdevimab, as a treatment option for patients with confirmed COVID-19 who do not require oxygen supplementation and who are at high risk of progressing to severe COVID-19. (Source: Roche Media News)
Source: Roche Media News - February 26, 2021 Category: Pharmaceuticals Source Type: news
Roche receives positive CHMP opinion for Evrysdi, the first and only at home spinal muscular atrophy (SMA) treatment with proven efficacy in adults, children and infants two months and older
Basel, 26 February 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Evrysdi ™ (risdiplam) for the treatment of 5q spinal muscular atrophy (SMA) in patients 2 months of age and older, with a clinical diagnosis of SMA Type 1, Type 2 or Type 3 or with one to four SMN2 copies. SMA is a leading genetic cause of death in infants and 5q SMA is the most common form of the disease . SMA causes progressive muscle weakness and atrophy, and significant unmet need remains, particularly in adults livi...
Source: Roche Media News - February 26, 2021 Category: Pharmaceuticals Source Type: news
Roche announces results from Evrysdi (risdiplam) study in infants with Type 1 spinal muscular atrophy (SMA) published in New England Journal of Medicine
Basel, 25 February 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the New England Journal of Medicine has published Evrysdi ™ (risdiplam) data from the dose finding Part 1 of the pivotal FIREFISH study in infants with symptomatic Type 1 spinal muscular atrophy (SMA). The data show that treatment with Evrysdi at 12 months helped 90% (19/21) of these infants survive without permanent ventilation and 33% (7/21) sit withou t support for at least 5 seconds, which is not normally seen in the natural course of the disease. The study also found that treatment with Evrysdi increased the levels of survival of motor...
Source: Roche Media News - February 25, 2021 Category: Pharmaceuticals Source Type: news
New phase III data show Roche ’s faricimab is the first investigational injectable eye medicine to extend time between treatments up to four months in two leading causes of vision loss, potentially reducing treatment burden for patients
Basel, 12 February 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced detailed results from four phase III studies of its investigational bispecific antibody, faricimab, for the treatment of diabetic macular edema (DME) and neovascular or “wet” age-related macular degeneration (nAMD). The studies consistently showed that faricimab, given at intervals of up to four months, offered non-inferior vision gains compared to aflibercept, given every two months. Approximately half of people eligible for extended dosing with faricimab were able to be treated every four months in the first year in the YOSEMITE and RHINE st...
Source: Roche Media News - February 12, 2021 Category: Pharmaceuticals Source Type: news
FDA grants Breakthrough Device Designation for Roche's Elecsys Growth Differentiation Factor-15 (GDF-15) assay to help identify patients suitable for innovative treatment addressing unintentional weight loss in cancer patients
Basel, 8 February 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to their Elecsys ® GDF-15 assay as a companion diagnostic (CDx) in cancer treatment. This in vitro diagnostic immunoassay is intended for measurement of Growth Differentiation Factor-15 (GDF-15) in cachectic patients 18 years of age and older with solid tumours for treatment with Pfizer Inc. ' s (NYSE: PFE) investigational drug PF-06946860. (Source: Roche Media News)
Source: Roche Media News - February 8, 2021 Category: Pharmaceuticals Source Type: news
Roche reports solid results in 2020
Commenting on the Group ’s results, Roche CEO Severin Schwan said: “Roche continues to make important contributions to fighting the COVID-19 pandemic. We developed in record time a comprehensive portfolio of diagnostic solutions and entered new partnerships to develop and produce effective COVID-19 medicines. The deman d for our new medicines which benefit people living with serious conditions, such as cancer, multiple sclerosis, haemophilia and spinal muscular atrophy, remains high. Based on our rejuvenated portfolio and the significant progress made in developing our product pipeline, Roche is strongly positione d fo...
Source: Roche Media News - February 4, 2021 Category: Pharmaceuticals Source Type: news
Roche announces the upcoming launch of the SARS-CoV-2 Rapid Antigen Test Nasal allowing for patient self-collection
Basel, 01 February 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced it has obtained the CE mark for its new SARS-CoV-2 Rapid Antigen Test Nasal. The test will be available in countries accepting the CE mark by mid-February 2021. In comparison to the existing Roche SARS-CoV-2 Rapid Antigen Test, the SARS-CoV-2 Rapid Antigen Test Nasal collects the sample from the front area of the nose instead of the nasopharynx, resulting in a simplified and faster testing procedure1. This testing method can help reduce overall patient discomfort, particularly in sensitive individuals such as children, elderly people and/or people...
Source: Roche Media News - February 1, 2021 Category: Pharmaceuticals Source Type: news
Roche renews partnership with Sysmex to deliver haematology testing solutions
Basel, 25 January 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that, on 14 December, 2020, it signed a Global Business Partnership Agreement* (GBP) with Sysmex. Under this new framework, the parties renewed their commitment to the long standing Distribution, Sales and Service (DSS) agreement, allowing Roche to continue to distribute Sysmex haematology products, including instruments and reagents.2 This GBP sees the introduction of an IT Solutions Collaboration Agreement. In the newly defined collaboration, the two companies have agreed to utilise their respective IT platforms to improve customer experience, in...
Source: Roche Media News - January 25, 2021 Category: Pharmaceuticals Source Type: news
Roche ’s faricimab meets primary endpoint in two global phase III studies and shows potential to extend time between treatments up to 16 weeks for people with neovascular age-related macular degeneration
Basel, 25 January 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced positive topline results from two identically designed global phase III studies, TENAYA and LUCERNE, evaluating its investigational bispecific antibody, faricimab, in people living with neovascular or “wet” age-related macular degeneration (nAMD). Both studies met their primary endpoint and showed that people receiving faricimab injections at fixed intervals of up to every 16 weeks achieved visual acuity outcomes that were non-inferior to those receiving aflibercept injections every eight wee ks. Nearly half (45%) of people in both studies were...
Source: Roche Media News - January 25, 2021 Category: Pharmaceuticals Source Type: news
Roche Annual General Meeting 2021: Exercising of shareholder rights via the independent proxy
Basel, 18 January 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that unfortunately it will not be possible for shareholders to attend the Annual General Meeting in person owing to the ongoing pandemic. Our main concern is to protect our shareholders from any potential health risks that may arise because of the ongoing difficult pandemic situation. As a precautionary and prudent measure, the Board of Directors has decided to conduct the Annual General Meeting of Roche Holding Ltd on Tuesday, 16 March 2021, in accordance with Art. 8 of the Federal Act on the Statutory Principles for Federal Council Ordinances on ...
Source: Roche Media News - January 18, 2021 Category: Pharmaceuticals Source Type: news
Roche confirms US government agreement to purchase additional doses of Regeneron ’s casirivimab and imdevimab
Basel, 12 January 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today confirmed that the U.S. Department of Health and Human Services (HHS) and the Department of Defense (DOD) will purchase additional supply of Regeneron ’s casirivimab and imdevimab antibody cocktail for use in non-hospitalised COVID-19 patients as part of Operation Warp Speed. The US government said it will provide these additional doses at no cost to patients, though healthcare facilities may charge fees related to administration, and will conti nue to coordinate allocation of the antibody cocktail to state and territorial health departments. Under the new...
Source: Roche Media News - January 12, 2021 Category: Pharmaceuticals Source Type: news
Roche to present updated data confirming Tecentriq in combination with Avastin substantially improves overall survival in people with the most common form of liver cancer
Basel, 12 January 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) will present updated overall survival (OS) data from the Phase III IMbrave150 study evaluating Tecentriq ® (atezolizumab) in combination with Avastin® (bevacizumab), compared with sorafenib, in people with unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy. (Source: Roche Media News)
Source: Roche Media News - January 12, 2021 Category: Pharmaceuticals Source Type: news
Roche launches two digital pathology image analysis algorithms for precision patient diagnosis in breast cancer
Basel, 11 January 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the CE-IVD launch of its automated digital pathology algorithms, uPath HER2 (4B5) image analysis and uPath Dual ISH image analysis for breast cancer to help determine the best treatment strategy for each patient. The image analysis algorithms use artificial intelligence to support pathologists in making faster, more accurate patient diagnoses in breast cancer. (Source: Roche Media News)
Source: Roche Media News - January 11, 2021 Category: Pharmaceuticals Source Type: news
